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DACOGEN

NDA

DECITABINE | N021790 | OTSUKA PHARMACEUTICAL CO LTD

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1 NCT07472322	Phase 1/2	Not Yet Recruiting	University of Wisconsin, Madison	31	2026-07 → 2031-05
Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)NCT06577441	Phase 2	Recruiting	National Cancer Institute (NCI)	54	2025-06-12 → 2027-03-01
Decitabine and Nivolumab in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck NCT07216833	Phase 1	Withdrawn	Case Comprehensive Cancer Center	—	2026-01 → 2027-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part B Spending

CMS physician-administered drug spending for Dacogen (2023)

Total Spending

$2.4M

Total Claims

28,323

Beneficiaries

1,443

ASP Price

—

HCPCS: J0894 — Injection, decitabine, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain17 active DMFs3 inactive

16 active API suppliers hold Drug Master Files for this ingredient.

SCINOPHARM TAIWAN LTDDECITABINE

DMF 233872009

DR REDDYS LABORATORIES LTDDECITABINE

DMF 235962010

VERANOVA LPDECITABINE

DMF 252182011

INTAS PHARMACEUTICALS LTDDECITABINE

DMF 253172011

CQ INTERNATIONAL CO INCDECITABINE

DMF 259882012

SUN PHARMACEUTICAL INDUSTRIES LTDDECITABINE

DMF 262562013

ITF CHEMICAL LTDADECITABINE

DMF 267082012

EMCURE PHARMACEUTICALS LTDDECITABINE MONOHYDRATE

DMF 269482013

SHILPA PHARMA LIFESCIENCES LTDDECITABINE

DMF 274882013

SCINOPHARM TAIWAN LTDDECITABINE

DMF 275432013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDDECITABINE

DMF 296972015

QILU PHARMACEUTICAL CO LTDDECITABINE

DMF 297492015

RELIANCE LIFE SCIENCES PVT LTDDECITABINE

DMF 298322016

MSN LABORATORIES PRIVATE LTDDECITABINE

DMF 313542017

WUHAN CALMLAND PHARMACEUTICALS CO LTDDECITABINE

DMF 323882017

FARMHISPANIA SADECITABINE

DMF 341632019

SHANDONG NEW TIME PHARMACEUTICAL CO LTDDECITABINE

DMF 402902024

FERRO PFANSTIEHL INCInactiveDECITABINE

DMF 128511998

FRESENIUS KABI ONCOLOGY LTDInactiveDECITABINE

DMF 255322011

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveDECITABINE

DMF 280482014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Dec 18, 2024	SUPPL -23	View Letter (PDF)
Jun 30, 2020	SUPPL -25	View Letter (PDF)
Dec 31, 2018	SUPPL -21	View Letter (PDF)
Dec 20, 2018	SUPPL -20	View Letter (PDF)
Mar 18, 2010	SUPPL -6	View Letter (PDF)
May 5, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: May 2, 2006

No patent or exclusivity listings for this strength.